NCT00705159

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 1 Week – 6 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.

Conditions

• Conjunctivitis

Interventions

Type	Name	Description
DRUG	loteprednol etabonate and tobramycin	Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
DRUG	loteprednol etabonate	Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
DRUG	Tobramycin	Topical ocular administration of Tobramycin QID for 14 days.
DRUG	Vehicle of Zylet	Topical ocular administration of the vehicle of Zylet QID for 14 days.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2008-06-25
• Last updated: 2015-03-24
• Results posted: 2011-08-11

Locations

1 site across 1 country: United States